On Patenting

There are two very large industry groups that have different outcomes in mind for the patent system. The healthcare industry would like stronger protection for inventors. The high-tech industry would like stronger protection for producers. These goals aren’t necessarily diametrically opposed, but they are at odds”

– Drew Curtis, founder of Fark.com, “How I beat a Patent Troll”

I know a lot of people in both the high-tech industry and biotech and biology-related research are waiting with bated breath a decision by the Supreme Court. This case is Association for Molecular Pathology v. Myriad Genetics, (I’ll call it Myriad, in italics, for short) and how the court decides may affect the patent law landscape. Pundits believe the Supreme Court intends to make an influential decision in this case, since the real-world implications of the case are almost irrelevant: The gene patents in question are set to expire in 2014, and the court could have easily ignored the decision and let the arguing parties move on with their lives. In this essay, I will make my personal assessment of this case and present what I believe will be the repercussions in this case. Finally, I’ll talk about indysci’s position on patenting in general, and how to move forward with intellectual property in biology.

Please bear in mind that I’m not a lawyer, nor a patent expert, and although I’ve asked some brilliant friends at the nexus of science and law to help me out with this essay, none of us have had the time nor the desire to comprehensively understand the details of the case, so this is a somewhat limited opinion.

To begin, I’d like to address the issue of what, exactly it means to “patent a gene”. A lot of breathless words have been expired on this very topic by people who may or may not have actually looked into the mechanism by which this is achieved. The very phrasing “gene patent”, arguably poorly chosen by the patent filers themselves, is a somewhat loaded term that risks ascribing, in my opinion, more malice to the patent holders than is warranted. How can one patent information that is encoded in our genome itself? Information that, potentially everyone carries within themselves? Do we infringe on this patent just by walking this Earth? This misperception is easily forgiven, as it seems to have tripped up the smartest of minds:

I hope that an awareness of the Human Genome Project’s history will guide the Court to the correct decision that human genes, as products of nature, should not be patented…. A scientist does not – and should not – expect to obtain a legal monopoly controlling the information encoded by human genes.”
– James Watson, PhD, Nobel Laureate for discovery of DNA double helix, Amicus Curiae brief for Myriad.

So let’s be explicit here. I’ll focus on three broad categories of claims that Myriad patented, these are distributed over 7+ patents. For ease of explanation, my categories are sorted by what their ramifications are for breast cancer gene testing; the patents themselves are divided along a mish-mash of these categories and the particular (BRCA1 and BRCA2) gene in question1. Examination of the Myriad claims in this fashion provides general insight to how the US intellectual property system can award (limited) privilege over the use of genetic knowledge. The first category consists of artificial molecules that contain the patient’s genetic information. The second category consists of artificial molecules that could directly detect the patient’s genetic information. The third category consists of the methods by which one uses these artificial molecules to determine if a patient is at risk for breast cancer. I think it’s reasonable to say that these patents together create a de facto legal monopoly controlling the commercial use of this information – for now. But I don’t think this can be considered an absolute monopoly on the information contained in the genes, because we can’t rule out future commercial technologies that could easily break these patents. Indeed there are such technologies already commonly used in research, which are on the brink of large scale commercialization.

The first category concerns the process called PCR. This is a standard workhorse process of molecular biology. Briefly, Two short strands of artificial DNA, called “primers” are mixed in with a “template” DNA, in this case, the patient’s DNA. The primers are basically addressing mechanisms: They are usually, in this application, direct copies of short stretches (20-40 bases) of the template DNA, and in the PCR process, billions of copies (“amplicons”) of the template DNA sequence between the two primers are generated via an exponential process. It’s important to note, that the primers and the copied template DNA are nothing more than physical molecules, and importantly, molecules that would not exist in nature, except for the human intervention of the experimenters. The reason why this process is so useful is that typically a sample of the patient’s DNA will not have many copies of the DNA, and having amplified the DNA segment, one can then very easily run a battery of tests on it with ease, and without worrying about squandering precious source DNA. The Myriad patents’ claims in part cover the “primers” and the “amplicons”.

The second category concerns the process of making “DNA chips”. This is basically the technology that 23andMe uses to genotype its users. One makes a “DNA chip” by tethering short strands of DNA, not unlike the “primers” described above, to the chip. Usually these strands also have one or more glowing molecules on the end. When the patient DNA sees these short DNA strands, the strands on the chip invade the patient’s DNA, specifically at the address specified by the strand sequence. Cleverly, the address of these short segments contains the disease-causing mutation, and the presence or absence of the mutation alters the brightness of the glowing molecule. The chip will be printed with DNA strand sequences defined at specific locations, allowing a single photograph to read out millions of mutations. The Myriad patents’ claim these short DNA strands.

Importantly, in both of these categories, the Myriad patents are careful to claim something precedented – molecules. These molecules are artificial, and created through deliberate human intervention. I think there may be clever ways of breaking the patent on these covered entities (likely a moot point in the particular case of the BRCA genes, given the impending patent expiry). I also believe other technologies, such as whole-genome sequencing or exome sequencing bypasses specific gene patents, and could give patients access to this information without breaking the Myriad patents. However, by my reading in terms of a legal (versus technological) challenge I think these two categories are pretty airtight. Moreover, the covered molecules are absolutely required for all of the conventional commercial techniques for gaining knowledge about a patient’s BRCA genes.

The challenge appearing before the supreme court in the Myriad case also concerns itself with a third broad category of claims: The methods. I suspect that the litigants felt empowered to challenge this through the judiciary because of the court’s aggressive work on the concept of a “business method”. Although people have been trying to patent “business methods” since the dawn of the US patent office, there’s something generally unsettling about the concept, and the patent office and supreme court have frequently (but not comprehensively) ruled against business patents. As a result of these attempts, there has emerged the general guideline that a method patent must claim a “machine” or “a transformation of physical, tangible material”. One possibility is that the court could make a decision codifying a second guideline in the Myriad case that effectively limits the patentability of gene-related methods. But such a decision would be unusually ‘activist’ and I think it’s more likely that the court will argue that congress has broad, constitutional leeway to allow for patenting “for the promotion of the useful arts”, thus punting the decision for any such guidelines to congress, much like it did with respect to copyright time limits in Eldred v. Ashcroft (a very unpopular and contentious – but I think, legally correct decision2). After all, the lawyers for Myriad have argued correctly that the patenting landscape “promotes” their activities, and it would seem hard to claim their activities are not “useful”.

Some of the methods claimed in Myriad’s patents, however, I think, are likely to fall due to overbroadness and obviousness. For example, patent 6033857 claims (claim 1) the method of examining a gene sequence and comparing it against a reference gene as a diagnostic technique. Since this isn’t a physical transformation or a machine, it fails the general test for method patents, although I am not sure if the supreme court will be the venue where this claim gets struck down.

As often is the case, morality is not necessarily the same question as legality. It’s not self-evident to me that the privilege of restraining others from peacefully using their minds and labor is morally acceptable. Then there’s the social effort and capital that’s wasted on this pursuit, not only when it’s abused by trolls but sometimes as a matter of course. That’s why you’ll see that all of the documentation we generate will be released to the public under either copyheart (where possible) or a creative commons licence (where necessary). indysci.org also has, baked into its bylaws, a prohibition against execution of patents or intellectual property, and we intend to publicise patentable products using “Statutory Invention Registration” to afford it maximal legal protection against predatory patenting. For now, though, among biological research entities, indysci is an outlier. Basically all for-profit and non-profit research organizations have aggressive IP policies, and by default, attempt to assert intellectual property over the product of their employees, even when the research is funded by public monies and not private investment.

We’ve learned a lot from how the high-tech industry (both in for- and non-profit contexts) has embraced openness, releasing their product unencumbered by intellectual property. And certainly high-tech industry has enjoyed explosive growth, which belies the dogma that protection is necessary for profit. Yet these ideas about how to run a community have not yet truly spread to biotech. With the advent of bioinformatics, we’ve seen the free culture philosophy begin to infiltrate biology. But bioinformaticists are often still viewed with relative derision by “wetlabbers” who use their hands to do science, and I think this has been a little bit of an obstacle to getting these ideals adopted. Perhaps more importantly, unlike for software (early pioneering examples of linux, apache, wikipedia) in recent memory we don’t have a high-functioning example of unpatenting in biology or pharmaceuticals; it’s too easy to dismiss that it simply wouldn’t work – even in the face of a powerful emotional imperative – in the Myriad case, the plight of women who must pay a premium to make important, informed decisions about their own health.

It is inevitable that change will meet resistance, even among those primed to receive it; consider the words of Judge Richard Posner, who famously intervened to overturn silly patents in the Apple vs. Motorola case: “So pharmaceuticals are the poster child for the patent system… [although] most industries could get along fine without patent protection.” For inspiration, I look to Jonas Salk, who refused to patent the polio vaccine. The polio vaccine was hardly inconsequential; it saved millions upon millions of lives and improved many times more – and his choice is more powerful considering that in retrospect eradication in the third world might not have been possible so swiftly with the added expense of IP licensing.

As someone who agitates for the ultimate abolition of patents, I think it’s wise that free culture advocates hold their anticipation of a sea-changing decision in this case. The court may even in toto uphold the Myriad patents, in what I would consider to be a legally correct decision, a decision for which I would not impugn the justices. Moving forward, I think we have to create examples where intellectual freedom works to improve society, and even to profit (if at a lesser magnitude than conventional innovators) those brave or stupid enough to try. It would do to approach the issue with some measure of patience – there will be failures along the way – and remember Eric Raymond’s dialectic model:

I expect the open-source movement to have essentially won its point about software within three to five years (that is, by 2003–2005). Once that is accomplished, and the results have been manifest for a while, they will become part of the background culture of non-programmers. At that point it will become more appropriate to try to leverage open-source insights in wider domains.”